FDA Approval Pending Over New Implant Designed to Treat Opioid Addiction

Share

Over the next few months, the U.S. Food and Drug Administration (FDA) is expected to decide whether or not to approve a groundbreaking new implant designed to treat addiction to heroin and prescription painkillers. The device, which comes at a time when federal health authorities are pushing to expand the use of medications to treat opioid addiction across the country, could be a game changer for the harm reduction industry. However, the product has raised some safety concerns since it came out in 2003, Maine Public Broadcasting reports.

The new medication, called probuphine, works by delivering a steady dose of the anti-addiction drug buprenorphine through four small implants in a patient’s arm over the course of six months. Made by New Jersey–based Braeburn Pharmaceuticals, the implant, which can be inserted by doctors in as little as 15 minutes, is specifically intended for people who have been taking buprenorphine successfully for a while. Clinical studies have shown that it is highly effective at helping to ease the symptoms of withdrawal, decrease cravings and cut the risk of relapse.

Researchers also say there are several tactical advantages to probuphine over other addiction medications like Suboxone or methadone, which often come in pill form, liquids or films that dissolve under the tongue. First, it helps patients adhere to the medication better. The implant also ensures that the drug doesn’t end up stolen, accidentally in the hands of children, or diverted and sold on the street.

However, addiction specialists have also raised serious concerns over the safety of probuphine, such as what might happen to someone with an implant in an emergency where surgery or anesthesia is necessary. Others are raising questions about how to safely transition patients from other buprenorphine-based products to the implant, especially for addiction patients who may need extra oral doses of the drug to stay on track with their progress.

That being said, at a public hearing on probuphine in January, clinical trial investigators pointed to a recent Phase III clinical trial showing that at the end of a six month trial period, 85 percent of people given the implant showed no evidence of illicit drug use, compared with 72 percent of those given the oral form of the drug. The FDA advisory committee voted 12-5 to recommend its approval.

According to the Substance Abuse and Mental Health Services Administration, addiction patients who are given “medication-assisted treatment” such as probuphine, buprenorphine or methadone can cut their overall risk of death in half. Opioid treatment programs can also halve a person’s risk of developing HIV and seriously decrease their likelihood of becoming infected with the hepatitis C virus (HCV), which is currently on the rise among young injection drug users in the United States.